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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number CAR-170-C
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/25/2022
Event Type  malfunction  
Manufacturer Narrative
The cartridge was received for evaluation and revealed a leak in the venous line.A device history record (dhr) review was conducted for the reported lot number and revealed the product was released for distribution having met quality and manufacturing specifications and requirements.The instructions for use states "check the system for blood and fluid leaks during treatment, and pay close attention to the blood line and access connections".
 
Event Description
A report was received on (b)(6) 2022 from a 37 year old male patient with a medical history including end stage renal disease, who stated an unspecified amount of blood leaked inside the cycler during a hemodialysis treatment on (b)(6) 2022.Additional information was received on (b)(6) 2022 from the home therapy nurse (htn) who stated the patient did not experience any symptoms and there was no medical intervention required.Following the event, the patient continues to treat with the nxstage system.
 
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Brand Name
NXSTAGE SYSTEM ONE
Type of Device
HIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
Manufacturer (Section G)
MEDIMEXICO S. DE R. L. DE C. V
av. valle imperial no. 10523
parque industrial valle sur
tijuana 22180
MX   22180
Manufacturer Contact
paula rogalski
nxstage medical, inc.
350 merrimack street
lawrence, MA 01843
MDR Report Key15401428
MDR Text Key306168005
Report Number3003464075-2022-00048
Device Sequence Number1
Product Code KDI
UDI-Public+M535CAR170C0/$$102320477091+
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/01/2023
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number20477091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2022
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/25/2022
Initial Date FDA Received09/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
Patient SexMale
Patient Weight69 KG
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